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Clinical Research

We undertake:-


Healthy Volunteer Studies


Clinical projects to evaluate and/or compare wound healing therapies ranging from Case Studies to multi-centre RCTs.


Clinical projects to generate chronic wound-derived materials (e.g. wound fluids for laboratory investigations by sponsor companies).

Our services include:-


Sourcing & evaluation of investigators/centres


Preparation of study documentation

  Protocol

  Case Record Forms

  Patient Information Sheet

  Patient Consent Form


Ethics submission & liaison (UK National Research Ethics Service)


Negotiation with UK-NHS Research & Development (site specific)


Study Monitoring & logistics


Preparation of study reports for internal use or peer review publication


Image (& acetate tracing) analysis of clinical trial wound photographs
clinical wound healing research
Example

Multiple (10) case study evaluation of a new foam dressing under short-stretch compression

Purpose – to support out-licensing of product

Product status – CE marked device

Wound type – venous ulcer

Wound status
v
 low to moderate exudation
v
 non-infected (clinical signs)
v
 > 3 months duration

Assessments (over 6 weeks)
v
Closure (image analysis)
v
Pain (between & at dressing change) - VAS
v
Tissue composition of wound (image analysis)
v
Peri-wound tissue status
v
Ease of use (relative to comparable product)
v
Adverse effects  

Findings
v
Dressing performed well.
v
Considered equivalent to similar products – by clinician
v
No adverse effects

Outcome
v
Product has been out-licensed by client
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Clinical Trial Microbiology
We can provide microbiological analysis of clinical trial samples (wound  biopsies or surface wound swabs) using conventional microbiological  techniques.